Amiodarone Hydrochloride
NDC Package 55648-780-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amiodarone Hydrochloride is a . Marketed by Wockhardt Limited, this product is identified by NDC 55648-780 and is authorized under FDA application ANDA077834.

Identification & Billing

NDC Package Code
55648-780-01
Package Description
1 VIAL in 1 CARTON / 18 mL in 1 VIAL
Product Code
55648-780
11-Digit Billing Format
55648078001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amiodarone Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Wockhardt Limited
FDA Application #
ANDA077834
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-30-2008
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55648-780-01 identifies a specific commercial package of 1 vial in 1 carton / 18 ml in 1 vial of Amiodarone Hydrochloride, labeled by Wockhardt Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Wockhardt Limited on October 30, 2008. The current certification is valid through December 31, 2019.

How is this Wockhardt Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55648078001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
55648-780-01
11-Digit CMS (5-4-2)
55648-0780-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.